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Pfizer vs Moderna
competition and race speed up

By The Editor - Created 20 november 2020 - Updated 25 november 2020

The path is gradually clearing for laboratories battling against Covid-19. And the race to bring a vaccine to the market has dramatically sped up during the past weeks with several announcements by Pfizer and Moderna.

Both drugmakers have released promising interim results from their Phase 3 trials. They also reported mild or moderate side effects, mostly pain at the injection site, fatigue and aching muscles, and joints for a day or two.

November 9, Pfizer and German biotechnology company BioNTech indicated early findings of their vaccine, BNT162b2. They showed that the product vaccine was more than 90 % effective, after 94 patients developed Covid-19, out of 44, 000 volunteers. Half the participants received a placebo and half the vaccine.

November 16, Moderna released data on its vaccine candidate, mRNA-1273, which was developed in collaboration with the U.S. government. Its vaccine appears to be 94.5% effective against the disease, after 95 people out of the 30,000 volunteers came down with Covid-19.

New announcement on November 18, Pfizer and BioNTech revaluated their results and announced that after conducting the final efficacy analysis in their ongoing Phase 3 study, their product met all of the study's primary efficacy endpoints, with an efficacy rate of 95 %. In global phase 3 trials involving more than 43,000 people, 170 were observed to have contracted coronavirus, out of which 162 had been given a placebo. "Safety data milestone required by the FDA for Emergency Use Authorization (EUA) has been achieved" and the companies will submit their Covid-19 vaccine for US and EU emergency approval "within days".

The companies submitted a request to the FDA on November 20, seeking emergency-use authorisation (EUA) for their Covid-19 vaccine candidate. The companies noted that the filing will "potentially enable use of the vaccine in high-risk populations in the US by the middle to end of December". A vaccines and related biological products advisory Committee discussion is scheduled for December 10.

Moderna will take longer to communicate on its final efficacy analisys, because it took longer to enroll trial participants.

Several hurdles will still have to be cleared in the future: one concerns production. Both Moderna and Pfizer's vaccines will require two shots. Moderna's two doses are administered a month apart, while Pfizer's are given three weeks apart. Pfizer has said it will have as much as 50 million doses of its vaccine manufactured by the end of this year, and another 1.3 billion next year. Moderna will have 20 million doses available by the end of this year and another 500 million to 1 billion next calendar year.

If the two products seem to be similar in terms of trials results, calendar of approval submission and production, there is one major difference: while mRNA-1273 can be stored for up to six months at -20 degrees celsius, and is stable in a normal fridge at temperatures of between 2 and 8 degrees celsius for 30 days, by contrast, Pfizer and BioNTech's BNT162b2 must be kept at approximately -75C during transit, which can complicate distribution.

PHARMAnetwork has gathered in issue 47 of the magazine the main agreements concluded with CDMOs

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